Federal Register notice: FDA determines that Mallinckrodts Ofirmev (acetaminophen) injection, 1,000 mg/100 ml, was not withdrawn for safety or effecti...
FDA denies a citizen petition from advocacy group Public Citizen that urged it and the Drug Enforcement Administration to open proceedings to place ga...
Merck says it has identified the root cause of nitrosamine formation in certain Januvia (sitagliptin) batches.
Federal Register notice: FDA classifies prognostic tests for assessing liver-related disease progression into Class 2 (special controls).
The HHS Inspector General says FDA has concurred with recommendations on steps to improve its management of IT acquisition contracts.
Two CDER officials describe work being done under the Biosimilar User Fee Amendments 3.
A Florida woman is sentenced to three years in jail for submitting a false affidavit to an FDA investigator looking into issues with a clinical trial ...
The DC Circuit Court of Appeals says Sanofi was entitled to new chemical entity exclusivity for its Aubagio and Sandoz is not entitled to exclusivity ...
